Brain Metastases

November 10, 2008

YM Biosciences released positive results from two phase II trials of nimotuzumab for the treatment of brain metastases and brain cancer. The first trial was a randomized, open, controlled trial in 30 subjects diagnosed with advanced non-small cell lung cancer (NSCLC) and unresectable brain metastases. The subjects received nimotuzumab (200 mg administered as weekly intravenous infusions over weeks 1-6) plus palliative radiation (40 Gy in four weeks) or palliative radiation alone. The primary endpoint was disease control rate (DCR- Complete Response + Partial Response + Stable Disease). Data are from the first 21 subjects. DCR was 91.6% for the nimotuzumab plus radiation arm compared to 44.4% for the radiation alone arm. Subjects treated with the combination had a median survival of 7 months compared to the control group for whom the median survival was 2.47 months (p= 0.0039). The second trial was a randomized, double blind phase II/III trial in 80 subjects with newly diagnosed high-grade glioma. Following biopsy, partial or total resection of the tumor, the subjects received six weekly infusions of placebo or nimotuzumab (200 mg) while also receiving radiotherapy, followed by a maintenance dose of nimotuzumab or placebo every 21 days. The treatment duration was one year. Results are from the first 65 enrolled subjects. The median survival time for the subjects treated with nimotuzumab plus radiotherapy was 16.43 months, while the median survival time for the placebo arm was 10.49 months. Nimotuzumab was well tolerated in both studies.

YM Biosciences released positive results from two phase II trials of nimotuzumab for the treatment of brain metastases and brain cancer. The first trial was a randomized, open, controlled trial in 30 subjects diagnosed with advanced non-small cell lung cancer (NSCLC) and unresectable brain metastases. The subjects received nimotuzumab (200 mg administered as weekly intravenous infusions over weeks 1-6) plus palliative radiation (40 Gy in four weeks) or palliative radiation alone. The primary endpoint was disease control rate (DCR- Complete Response + Partial Response + Stable Disease). Data are from the first 21 subjects. DCR was 91.6% for the nimotuzumab plus radiation arm compared to 44.4% for the radiation alone arm. Subjects treated with the combination had a median survival of 7 months compared to the control group for whom the median survival was 2.47 months (p= 0.0039). The second trial was a randomized, double blind phase II/III trial in 80 subjects with newly diagnosed high-grade glioma. Following biopsy, partial or total resection of the tumor, the subjects received six weekly infusions of placebo or nimotuzumab (200 mg) while also receiving radiotherapy, followed by a maintenance dose of nimotuzumab or placebo every 21 days. The treatment duration was one year. Results are from the first 65 enrolled subjects. The median survival time for the subjects treated with nimotuzumab plus radiotherapy was 16.43 months, while the median survival time for the placebo arm was 10.49 months. Nimotuzumab was well tolerated in both studies. Based on the data, YM Biosciences will continue with the studies as planne

October 14, 2002

Pharmacyclics reported results from an international, randomized controlled, phase III clinical trial investigating using Xcytrin on non-small cell lung cancer. The researchers concluded that when combined with whole brain radiation therapy (WBRT), Xcytrin significantly slowed the time to neurological progression and decreased deaths due to brain tumor in subjects with brain metastases from lung cancer. There was a significant improvement among the 401 intent-to-treat subject population, with the median time to neurologic progression at 3.8 months with WBRT alone versus 4.3 months with WBRT and Xcytrin. Among lung cancer patients, the median time to neurological progression was 3.7 months with WBRT alone versus 5.5 months with WBRT and Xcytrin. There was a significant reduction in brain tumor deaths among lung cancer subjects with 51% dying after receiving WBRT alone versus 32.2% after receiving WBRT and Xcytrin. Additionally, positive interim results were also reported for Xcytrin in an ongoing phase II clinical trial studying primary brain tumors (glioblastoma multiforme, or GBM).

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